Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 4 pages
Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 16December 2021 Peter Mark, M.D., Ph.D. Office of Vaccines Research and Review Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AN…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer FDA submission document — 2 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 6 pages
file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adxb-sas.txt[7/5/2023 10:22:52 AM]************************************************************************************************ ****************;** Program Name : adxb.sas **;** Date Created : 17Nov2021 **;**…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 24 pages
file:///J/...%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsympt-sas.txt[7/5/2023 10:22:54 AM]************************************************************************************************ **;** Program Name : adsympt.sas **;** Date Created : 17Nov2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 61 pages
INTERNAL REVIEW COMMITTEE CHARTER PFIZER INTERNAL USE ONLY The official version of this form is located in the electronic document management system. CT22 -GSOP -RF02 6.0 External Data Monitoring Committee and Internal Review Committee Charter T emplate 01-Nov-2019 Page 1 of 26 TMF Doc ID: 64.05 and 713.02 C4591001 Investigational BNT162 Vaccine Program PF-07302048 Version : 2.0 Date: 11-June-2020 090177e1945bf925\Approved\Approved On: 14-Jul-2020 13:56…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 4 pages
UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY , ET AL ., Plaintiff s, v. No. 4:2 2-cv-0915-P FOOD AND DRUG ADMINISTRATION , Defendant. ORDER “Democracy dies behind closed doors.” Detroit Free Press v. Ashcroft , 303 F.3d 681 ( 6th Cir. 2022). To help prevent that from happening, Congress enacted t he Freedom of Information Act (“FOIA”). It allows the public access to…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 1 page
UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY , ET AL ., Plaintiff s, v. No. 4:2 2-cv-0915-P FOOD AND DRUG ADMINISTRATION , Defendant. ORDER The Court believes it is necessary to schedule a status conference to discuss the current status of this case. The Court would like to resolve this matter as quickly and efficiently as possible. Therefore, the Court sets a …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 16 pages
UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, and PATRICK AND STEPHANIE DE GARAY, Plaintiffs, -against - FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:22- cv-915-P PLAINTIFFS ’ REPLY IN SUPPORT OF THEIR BRIEF FOR TIMELY PRODUCTION SCHEDUL E Case 4:22-cv-00915-P Document 28 Filed 04/12/23 Page 1 of 16 PageID 308 ii TABLE OF CONTENTS …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 24 pages
IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FO R TRANSPARENCY and PATRICK AND STEPHANIE DE GARAY, Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:22-cv-915-P DECLARATION OF SARAH B. KOTLER I, Sarah B. Kotler, declare as follows: 1. I am the Director of the Di vision of Freedom of Inform ation (“DFOI”), Office of the Executive…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 20 pages
1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY and PATRICK AND STEPHANIE DE GARAY, Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:22- cv-915-P DECLARATION OF BETH BROCKNER RYAN I, Beth Brockner Ryan, hereby declare as follows: 1. I am the Branch Chief of the Access Litigation and…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 36 pages
IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY and PATRICK AND STEPHANIE DE GARAY, Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:22- cv-915-P DEFENDANT UNITED STATES FOOD AND DRUG ADMINISTRATION’S BRIEF REGARDING FOIA PRODUCTION SCHEDULE LEIGHA SIMONTON UNITED STATES…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 26 pages
UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, and PATRICK AND STEPHANIE DE GARAY, Plaintiffs, -against- FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:22- cv-915-P BRIEF IN SUPPORT OF TIMELY PRODUCTION SCHEDUL E Case 4:22-cv-00915-P Document 24 Filed 03/08/23 Page 1 of 26 PageID 197 ii TABLE OF CONTENTS INTRODUCTION …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 1 page
UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY , ET AL ., Plaintiff s, v. No. 4:2 2-cv-0915-P FOOD AND DRUG ADMINISTRATION , Defendant. ORDER Before the Court is the Parties Joint Status Report . ECF No. 2 2. Having considered the Joint Report, related docket entries, and applicable law, the Court hereby ORDERS Plaintiffs to file their opening brief as to the…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 8 pages
1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY and PATRICK AND STEPHANIE DE GARAY, Plaintiff s, v. U.S. FOOD AND DRUG ADMINISTRATION , Defendant . Civil Action No. 4:22- cv-915-P INITIAL JOINT STATUS REPORT Plaintiffs Public Health and Medical Professionals for Transparency (“PHMPT”) and Patrick and Stephanie de…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 1 page
UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY , ET AL ., Plaintiff s, v. No. 4:2 2-cv-0915-P FOOD AND DRUG ADMINISTRATION , Defendant. ORDER Before the Court is the P arties Joint Scheduling Report. ECF No. 20. Having con sidered the Joint Report, related docket entries, and applicable law, the Court hereby ORDER S the Parties to file a joint status report…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 7 pages
Joint Sch. Report -- 1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY and PATRICK AND STEPHANIE DE GARAY, Plaintiff s, v. U.S. FOOD AND DRUG ADMINISTRATION , Defendant . Civil Action No. 4:22- cv-915-P JOINT SCHEDULING REPORT C ounsel for Plaintiff s Public Health and Medical Professionals for Transparency (“PHMPT”) …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 5 pages
UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY , ET AL ., Plaintiff s, v. No. 4:2 2-cv-0915-P FOOD AND DRUG ADMINISTRATION , Defendant. ORDER This Order is being sent to all counsel and unrepresented parties who have appeared. If there are other defendants who have not appeared, but who have been in contact with the plaintiff or plaintiff’s counsel, then the…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 21 pages
Answer– Page 1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY and PATRICK AND STEPHANIE DE GARAY, Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION , Defendant . Civil Action No. 4:22-cv -915-P ANSWER Defendant Food and Drug Administration (“FDA” or “Defendant”), by and through undersigned counsel, hereby answers the Complaint…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 And Moderna Court Documents
· 105 pages
1 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, and PAT RICK AND STEPHANIE DE GARAY, P laintiff s, -agai nst- FOOD AND DRUG ADMINISTRATION, D efendant. COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF Plaintiff s, as for their Complaint regarding Freedom of Information Act request s against the above-captioned Defendant, allege as follows: INTRODUCTION 1. On January 31, 2022, the Food and Drug…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer Court Documents
· 56 pages
1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL ) CASE NO. 4:21-CV-01058-P PROFESSIONALS FOR ) TRANSPARENCY ) ) FORT WORTH, TEXAS vs. ) ) DECEMBER 14, 2021 FOOD AND DRUG ADMINISTRATION ) 9:05 A.M. VOLUME 1 TRANSCRIPT OF SCHEDULING CONFERENCE BEFORE THE HONORABLE MARK T. PITTMAN UNITED STATES DISTRICT COURT JUDGE A P P E A R A N C E S: FOR THE…